FDA Approval Updates Enjaymo Indication for Cold Agglutinin Disease

Enjaymo is an immunoglobulin G subclass 4 monoclonal antibody.

The Food and Drug Administration (FDA) has expanded the approval of Enjaymo® (sutimlimab-jome) for the treatment of hemolysis in adults with cold agglutinin disease (CAD) to include patients with or without a history of transfusions.

Enjaymo, an immunoglobulin G subclass 4 (IgG4) monoclonal antibody, inhibits the classical complement pathway and specifically binds to complement protein component 1. This inhibition prevents deposition of complement opsonins on the surface of red blood cells, resulting in inhibition of hemolysis in patients with CAD.

The expanded approval was based on data from the CADENZA study (ClinicalTrials.gov Identifier: NCT03347422). Enjaymo had originally been approved based on data from Part A of the CARDINAL study, a single-arm, open-label trial (ClinicalTrials.gov Identifier: NCT03347396) in patients with CAD with a recent blood transfusion.

The phase 3, double-blind, placebo-controlled CADENZA study included patients with CAD without a recent history of blood transfusion (N=42). Results showed a statistically significant treatment effect for Enjaymo over placebo. The responder rate difference between Enjaymo and placebo was reported to be 58.78% (95% CI, 34.6-82.96; P =.0004.)

A participant was considered a responder if they did not receive a blood transfusion from week 5 through week 26 and did not receive treatment for CAD beyond what was permitted per protocol. Additionally, hemoglobin level must have increased to at least 1.5g/dL from baseline at the treatment assessment timepoint (defined as average of values from the week 23, 25, and 26 visits).

A statistically significant improvement of symptoms and impacts of fatigue, as measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, was also observed with Enjaymo vs placebo (LS mean difference of 8.93; 95% CI, 4.0-13.85; P <.001).

The updated labeling for Enjaymo also includes long-term data from Part B of the CARDINAL (2-year follow-up) and CADENZA (1-year follow-up) studies. In both trials, the signs and symptoms of recurrent hemolysis were observed 9 weeks after the last dose of Enjaymo.

Enjaymo is supplied as a 1100mg/22mL (50mg/mL) solution in a single-dose vial.


  1. FDA approves expanded label of Enjaymo® (sutimlimab-jome) to include long-term safety and efficacy for people with cold agglutinin disease. News release. January 25, 2023. https://www.news.sanofi.us/2023-01-15-FDA-approves-expanded-label-of-Enjaymo-R-sutimlimab-jome-to-include-long-term-safety-and-efficacy-for-people-with-cold-agglutinin-disease
  2. Enjaymo. Package insert. Sanofi; 2023. Accessed January 27, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761164s003lbl.pdf